Total 3 Full-time compliance manager job vacancies in carmona

Job Scope:

1. Maintain site-wide compliance by ensuring all activities and documentation are current, effective and in-use.

2. Ensure all Internal and External Audit including Third Party Audit Preparations are complete.

3. Assist in supplier accreditation/qualification and ensure compliance to required

documentation

4. Support in ensuring management of all Quality Management System-related

documents.

Duties & Responsibilities:

1.) Responsible in monitoring and maintaining completeness of documentation in all GMP processes in the company.

2.) Ensures all documentation for supplier accreditation/qualification are complete and current in compliance to regulations and customer requirements.

3.) Ensure annual training requirement for the company is complied with.

4.) Support safekeeping of all documents registered under Document Control Center.

5.) Facilitate Internal Quality Audit Team and its functional activities

6.) Facilitate all external audits (Regulatory and Certifying bodies, Clients/Customers)

6.) Support in executing continuous improvement actions and projects

7.) Ensure compliance to cGMP/GDP, FDA, Halal, FSSC, customer and other regulatory and statutory requirements.

8.) Provide assistance in deviation investigation, robust CAPA identification and implementation.

Job Scope:

1. Investigation and identifying the right root cause

2. Provide analytical and technical skills to maintain company quality services and products

3. Manages and supervise quality control laboratory activities

4. Supervision and leading staff

4. Ensure robust testing procedures and outputs and identifying mistakes or non-conformity issues.

Duties & Responsibilities:

1. Develops procedures by understanding customer requirements in order to have an effective quality control.
2. Ensure material and product specifications are in-place for supplier and monitoring compliances.
3. Collaborated with the Quality Assurance personnel for the implementation of systems, procedures and standards of operation to comply with company standards and local regulations.
4. Leads the establishments and implementation of procedures for sampling, recording and reporting data.
5. Supervises and guides all laboratory personnel to ensures quality in the process by which products are manufactured.
6. Final approver for all GxP documents.
7. Designated/alternate authorized person for batch release.
8. Appraises customer’s requirements and ensure satisfaction
9. Facilitate proactive solutions by collecting and analyzing quality data
10. Review and ensure all standards and policies are current
11. Keep records of quality reports, statistical reviews and relevant documentation
12. Make sure that Out of Specifications are investigated and resolved.
13. Ensure appropriate actions are taken in case of willful or negligent GMP violations up to and escalating to responsible management for any necessary disciplinary action.
14. Ensure all legal standards are met to maintain certifications of the laboratory.
15. Ensure appropriate and timely escalation for quality related matters.
16. Assess the conclusions of periodic review of process performance, product quality and the Quality Management System.
17. Monitor effectiveness of quality systems, including performance of GMP and internal audits, metrics monitoring and participation in management reviews.
18. Lead/Initiates/participates in any process improvements aimed at improving efficiency and savings
19. Ensure appropriate interface with authorities for any GxP related activities.
20. Decision on withholding products from distribution if needed, for resolution of quality or compliance issues or mandate market actions, up to and including recommendation for recall of product, following the relevant procedures.
21. Escalation of any issues due to inadequate resources (personnel, budgetary, etc) to perform quality oversight or duties.
22. Works collaboratively with other department for completion of investigation through root-cause analysis pertinent to product/customer complaint and other related non-conformities identified within the process in coordination with the department head.
23. Prepares and submits departmental monthly/quarterly KPI and other report on a timely basis
24. Lead and representative of Quality control for all regulatory and client audits and prepares necessary aids for external audits.
25. Facilitate the Quality Council Meetings and is responsible for the oversight of product quality and GMP compliance for all products manufactured or distributed from the site.

1)   Enhances the organization’s human resources by planning, implementing, and evaluating employee relations and human resources policies, programs, and practices

2)   Maintains the work structure by updating job requirements and job descriptions for all positions

3)   Supports organization staff by establishing a recruiting, testing, and interviewing program, counseling managers on candidate selection, conducting and analyzing exit interviews; and recommending changes

4)   Prepares new and regular employees for work assignments by establishing and conducting orientation and training programs

5)   Manages a standard salary band by conducting periodic pay surveys; scheduling and conducting job evaluations; preparing pay budgets, monitoring, and endorsing individual pay actions; and recommending, planning, and implementing pay structure revisions

6)   Ensures planning, monitoring, and appraisal of employee work results by training managers to coach and discipline employees, scheduling management conferences with employees, hearing and resolving employee grievances, and counseling employees and supervisors

7)   In coordination with the Management, ensures sustainability of the organization by identifying high potential employees and providing individual development plan necessary for succession planning program

8)   Implements employee benefits programs and informs employees of benefits by studying and assessing benefit needs and trends, recommending benefit programs to management directing the processing of benefit claims, obtaining and evaluating benefit contract bids, awarding benefit contracts, and designing and conducting educational programs on benefit programs

9)   Ensures legal compliance by monitoring and implementing applicable human resource policies and labor laws, conducting investigations, maintaining records, and representing the organization at hearings.

10)   Enforces management guidelines by preparing, updating, and recommending human resource policies and procedures

11)   Retains historical human resource records by designing a filing and retrieval system and keeping past and current records.

12)   Cultivates a professional and technical knowledge of employees by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies, as applicable.

13)   Completes human resource operational requirements by scheduling and assigning employees and following up on work results.

14)   Contributes to team effort by accomplishing related results as needed